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The Southern-Norway Post-Stroke Atrial Fibrillation Study

RecruitingNAAges 18 Years - anyAllSorlandet Hospital HF
NCT07407790 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Atrial fibrillation is a major cause of stroke, but it can be difficult to catch because it often comes and goes. The study will include approximately 450 adults who have had a stroke or a transient "mini-stroke" (TIA) within the last two weeks. Participants will be assigned by chance (randomized) to one of two groups: * Group 1 (Intervention): Participants wear the "ECG247 Smart Heart Sensor." This is a small patch that sticks to the chest and connects to a smartphone. It is worn continuously for up to 14 days, even after leaving the hospital. * Group 2 (Standard Care): Participants receive the standard hospital check-up. This typically inv

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, occurring within the last 2 weeks. * Initial evaluation of CT and/or CT angiography and/or MRI supports a diagnosis of TIA or ischemic stroke. * Available smartphone and access to the ECG247-app to be able to participate in the study. * Estimated life span of \>6 month * Permanent address in Norway * Informed Consent, Capable of giving signed informed consent or consent through proxy as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions * Known AF or atrial flutter prior to inclusion * Concomitant use of anticoagulation therapy or established contraindication to its use. To date this includes apixaban, rivaroxaban, edoxaban, dabigatran, warfarin and indirect thrombin inhibitors (except for short term thrombosis prevention). * Implanted pacemaker, ICD or loop-recorder * \>70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound * Pregnancy
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What it tests

  • Patch ECG
  • Standard Care (in control arm)
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Where

1 site
Sørlandet Sykehus HF
Kristiansand, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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